ABA requests that the FDA rescind its fiber definition

The American Bakers Association in a letter dated Feb. 13 requested that the Food and Drug Administration rescind its fiber definition.

“ABA believes the current definition of dietary fiber is not practical or workable and requests that FDA reconsider its definition,” the letter signed by Lee Sanders, the ABA’s senior vice-president, government relations and public affairs, said. “ABA has encountered numerous unintended consequences and unaccounted costs and burdens associated with the definition – likely a result of FDA’s issuance of the definition prior to thoroughly understanding and addressing the impact of the decision.

“ABA, therefore, requests that FDA rescind the definition of dietary fiber or at least stay the definition until it has adequately addressed the numerous concerns since it finalized the definition.”

The FDA, as part of a Nutrition Facts Panel final rule issued in the May 27, 2016, issue of the Federal Register, said naturally occurring dietary fibers meet the definition as do added isolated or synthetic fibers that the FDA has determined have a physiological effect beneficial to human health. The FDA in the Nov. 23, 2016, issue of the Federal Register issued draft guidance on evaluating the scientific evidence of beneficial physiological effects and requested public comment.

The Washington-based ABA gave its comments in the Feb. 13 letter. The ABA said the FDA did not provide ample time for industry input and for adequate research to understand the nature and benefits of ingredients currently declared in the definition of dietary fiber.

“It is clear that FDA still does not sufficiently understand dietary fiber enough to define it or regulate a definition,” the letter said.

The FDA identified seven non-digestible carbohydrates as meeting its dietary fiber definition: beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose. The ABA letter asked how the FDA will treat an ingredient that has an identical chemical structure to one of the seven approved non-digestible carbohydrates. The FDA lists cellulose as approved dietary fiber, for example, but other sources of cellulose, such as sugar cane fiber or sugar beet fiber, may have an identical chemical structure to the approved dietary fiber.

“ABA believes that if an ingredient has the same chemical structure as an approved NDC (non-digestible carbohydrate) and is in the same amount/proportion that demonstrated a beneficial physiological effect, then there is no reason to submit a citizen petition for that ingredient,” the letter said. “Instead, for such ingredients, FDA should revise the draft guidance to include an alternative to the citizen petition process, such as recommending that manufacturers keep records of such determinations.”

“Identifying these fibers as ‘isolated or synthetic’ has already caused significant confusion on top of an already extremely confusing and unworkable definition of dietary fiber,” the letter said.

Some ingredients may have the same name and yet have different traits, the letter said. Some corn hull fiber ingredients are highly processed and clearly “isolated and synthetic,” which means they need FDA approval before being declared dietary fiber, but other corn hull fiber ingredients are mechanically processed only and arguably are “intrinsic and intact,” meaning they do not require FDA approval.